MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) ASSAY; AHBS IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted siemens customer care center (ccc) to report a discordant, (b)(6) advia centaur xp (b)(6) result.A siemens customer service engineer (cse) was sent to the customer site.The cse checked the background counts, wash manifold connections, the base pump on both advia centaur xp instruments and found no system related issues.The customer was observing quality control (qc) errors and a total service visit was performed.There were no immediate system problems observed.The customer ran master curve material (mcm) on both advia centaur xp instruments and the values for mcm1 through mcm5 were within specifications.Siemens is investigating.Note: the reagent lot number 255 provided by the customer is considered to be incorrect.Siemens has no record of manufacturing (b)(6) reagent lot 255.A request for reagent lot number confirmation has been unanswered.The instructions for use (ifu) under the interpretation of results section states the following: "results should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.".
Event or Problem Description
A (b)(6) advia centaur xp (b)(6) result interpretation was obtained on a patient sample and considered to be discordant compared to a (b)(6) result interpretation when tested on an alternate advia centaur xp system.The customer performed repeat testing of the same sample on the original advia centaur xp system (sn (b)(4)), resulting (b)(6).The same sample was tested a second time on the same alternate advia centaur xp system ((b)(4)) with a (b)(6) result interpretation.A (b)(6) result was reported to the provider(s) as the correct result.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, advia centaur xp (b)(6) result interpretation.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2021-00484 initial report on 11-nov-2021 for a discordant, false reactive (positive) advia centaur xp anti-hbs2 (ahbs2) result interpretation obtained on a patient sample.24-nov-2021: additional information: siemens has competed the investigation.A customer service engineer (cse) went onsite did not observe any advia centaur xp system related issues.The advia centaur anti-hbs2 (ahbs2) master curve material (mcm) were evaluated on the two advia centaur xp systems.All mcm levels recovered within acceptable ranges.The patient sample when repeated recovered nonreactive with both analyzers.Siemens has reviewed the quality control (qc) data provided and there is no evidence of a system or reagent lot issue.Based on manufacturing records, reagent lot 255 is not a valid reagent lot number for anti-hbs2 (ahbs2).A request to the customer for reagent lot number confirmation has been unanswered.The potential cause of the discordant ahbs2 results observed by the customer with this one sample when using the advia centaur xp ahbs2 assay is unknown, however pre-analytical factors, a sample issue, or normal assay performance cannot be ruled out.The comparison of results section of the advia centaur xp anti-hbs2 (ahbs2) lists the 95% confidence interval (ci) for negative percent agreement as 96.7% - 98.5%, therefore a certain number of false positives can be expected with a given reagent lot.Based on the information provided, a product problem was not identified.The customer is operational.The assay is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) ASSAY
• Common Device Name: AHBS IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: stephen perry ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 12800774
• Report Number: 1219913-2021-00484
• Device Sequence Number: 17536690
• Product Code: LOM
• UDI-Device Identifier: 00630414591407
• UDI-Public: 00630414591407
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10698706
• Device Lot Number: 255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown